MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT RETROPUBIC DEVICE; TVT-CAL-RETROPUBIC

Catalog Number	830041BL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120); Pelvic Pain (4865)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed pain, urinary tract infection, and potential urinary retention (to be confirmed by ultrasound) after transurethral positioned sling surgery.Emergency strip removed one month after installation.The patient has had a urinary catheter for 9 days.The patient was diagnosed with urinary sphincter deficiency and was recommended to have an artificial urinary sphincter, which was rejected.".
Additional Manufacturer Narrative
This report is being submitted in accordance with the requirements of 21 cfr part 803.The information contained herein is based on data available to caldera medical at the time of submission.It may not have been thoroughly investigated or independently verified before the required reporting deadline.Submission of this report does not constitute an admission or conclusion by caldera medical that the product caused or contributed to the report event.Additional information was requested and the investigation results will be submitted.
Additional Manufacturer Narrative
Additional information: d5, e1, g2, h6, h11 investigation: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing number is (b)(4).

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• Common Device Name: TVT-CAL-RETROPUBIC
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDER MEDICAL SARL-NAUCHATEL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23341414
• Report Number: 3003990090-2025-01642
• Device Sequence Number: 20776012
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 830041BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female